Plasmid contract manufacturing organization (CMO) VGXI, Inc. and Geneos Therapeutics, Inc., a spin-out of Inovio Pharmaceuticals focused on developing DNA-based, Neoantigen-targeting personalized cancer immunotherapies, have entered into a long-term master supply agreement. The agreement will leverage VGXI’s experienced management team and decades of plasmid manufacturing proficiency to establish small-scale and rapid turnaround production services ideally suited for the personalized therapy approach. VGXI’s proprietary plasmid manufacturing process is recognized for providing the highest purity and supercoil fraction for DNA-based pharmaceuticals, in particular DNA vaccines. To meet urgent patient needs, this process will be optimized to enable turnaround times 1/10 of that for standard GMP grade products without compromising product quality. Completion of all process development, qualification, and validation activities at VGXI is projected by end of 2019, with clinical grade production of patient-specific DNA-plasmid based products for human clinical use by 1Q 2020.
 
“VGXI is excited to support the Geneos platform and enable the next generation of personalized cancer therapies. I have no doubt our technology and experienced team will ensure success for their product pipeline,” said Young Park, chief executive officer, VGXI.
 
Geneos Therapeutics is developing neoantigen-targeting, personalized cancer immunotherapies based on its clinically validated Exquisitely Personalized Immunotherapies for Cancer (GT-EPIC) Platform.
 
Niranjan Sardesai, chief executive officer, Geneos, said, “The GT-EPIC platform has demonstrated in preclinical models and clinical studies the safety of the platform and its ability to drive cancer antigen specific immune responses. A key challenge for treating advanced cancers is the tumor biopsy-to-treatment turnaround time for patient specific treatments which are only manufactured after the patient signs up for the treatment. Geneos is pleased to partner with the experienced team at VGXI to realize one of its key competitive advantages of rapid manufacturing for each patient.”